A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling
Full description
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.
Sex
Ages
Volunteers
Inclusion criteria
- 1.Male and female children with a minimum age of 6 years
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- Prepubertal as defined by Tanner staging
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- Growth hormone deficiency
Exclusion criteria
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- PGHD patients with uncontrolled pituitary tumor growth
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- Tumors within 3 mm of the optic chiasm
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- Serum ALT and/or AST >= 1.5 times the upper limit of normal range
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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